Product
Idursulfase-IT
Aliases
HGT-2310
Name
ELAPRASE
INN Name
idursulfase
FDA Approved
Yes
4 clinical trials
1 organization
1 indication
1 document
Indication
Mucopolysaccharidosis II (MPS II)Clinical trial
Post-trial Access Program: Idursulfase-IT (HGT-2310) in Conjunction With Intravenous Elaprase® in Pediatric and Adult Patients With Hunter Syndrome and Cognitive ImpairmentStatus:
Clinical trial
An Open-Label Extension for Subjects in Studies HGT-HIT-046 and SHP609-302 Evaluating Long-Term Safety of Intrathecal Idursulfase-IT Administered in Conjunction With Intravenous Elaprase® in Subjects With Hunter Syndrome and Cognitive ImpairmentStatus: Recruiting, Estimated PCD: 2034-01-01
Clinical trial
An Open-Label Extension of Study HGT-HIT-045 Evaluating Long-Term Safety and Clinical Outcomes of Intrathecal Idursulfase-IT Administered in Conjunction With Intravenous Elaprase® in Pediatric Patients With Hunter Syndrome and Cognitive ImpairmentStatus: Completed, Estimated PCD: 2024-04-30
Clinical trial
An Open Label Extension of Study HGT-HIT-094 Evaluating Long Term Safety and Clinical Outcomes of Intrathecal Idursulfase Administered in Conjunction With Elaprase® in Patients With Hunter Syndrome and Cognitive ImpairmentStatus: Completed, Estimated PCD: 2024-04-18
Document
DailyMed Label: ELAPRASEOrganization
Takeda Pharmaceuticals America, Inc.